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Opioids: FDA Eyes Better Prescriber Education, But Academics Urge Promotion Crackdown

Executive Summary

US agency is convening two-day workshop on federal efforts to support healthcare provider education about pain management and safe use of the drugs; two University of Washington researchers say agency needs to exercise stricter oversight of opioid marketing and promotion.

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'Not As Easy' OTC Codeine Label Changes Worry FDA Rx Product Advisors

FDA officials acknowledge at the Pediatric Advisory Committee Sept. 11 that labeling restrictions for opioid-containing Rx antitussives for pediatric cough wouldn't apply to labeling for codeine cough products available under an OTC monograph.

'Not As Easy' OTC Codeine Label Changes Worry FDA Rx Product Advisors

FDA officials acknowledge at the Pediatric Advisory Committee Sept. 11 that labeling restrictions for opioid-containing Rx antitussives for pediatric cough wouldn't apply to labeling for codeine cough products available under an OTC monograph.

Opioid Cough Restrictions: Pediatric Use, And Postmarket Studies, Likely Limited

US FDA advisory committee strongly recommends antitussives containing codeine or hydrocodone not be used by patients under age 18 years old, pointing to lack of modern evidence of benefit and known risks of respiratory depression and misuse. Expanding the contraindicated population could get some product sponsors off the hook for required pediatric studies.

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